Third party agreements – medicinal product in one territory/ device in another

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  • #12053

    Dear Colleagues,

    I was wondering if anyone has any experience with the below situation and could offer any advice please.

    We are a pharmacovigilance service provider and have a client MAH who holds MAs in the EU, where they market a medicinal product. The product is manufactured and distributed in Australia, where it is categorised as a class 3 medical device only. The manufacturer supplies the product to a single distributor in Australia, who distributes to our client MAH in the EU (medicinal product), but also to other companies/markets (all non-EU) where the product is classed as a device.

    In summary, the product is a medicinal product in EU (client MAH territories) but device in the rest of the world.

    Does anyone have any experience or advice on what type of safety information should be shared between the parties?

    Any suggestions or advice would be appreciated.

    Thank you 

    #12659

    Please note, that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as guidance. Please also refer to pharmacovigilance regulatory legislation, guidelines and your own company procedures.

    Dear PIPA Member,

    Thank you for your enquiry regarding third party agreements.

    In response to your enquiry, the most conservative approach would be that all safety (medicinal and device) should be shared equally between both parties, you would need to select what is relevant for the PV system (ICSR, product quality and aggregate reporting etc.) according to their local regulations.

    The important part from a PV drug perspective is that the EU laws expect that drug experiences globally are taken into account when looking at the risk benefit of its product.

    Therefore generally, the EU MAH would expect to hear of adverse events occurring with the product in territories where the product operates regardless of whether it is a drug or device in those areas.

    Of course, the other way round, the device territories will not expect the depth of information the drug territories expect, but device vigilance regulations are now getting stricter worldwide and some expectations would be there too.

    It is very important that whatever safety arrangements are agreed upon are detailed exhaustively in the contracts.

    I do hope this answers your query.

    Kind regards

    PIPA

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